Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY TO SUBJECT WITH RHEUMATOID ARTHRITIS.
3 other identifiers
interventional
195
11 countries
52
Brief Summary
The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Jun 2009
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedStudy Start
First participant enrolled
June 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2011
CompletedResults Posted
Study results publicly available
October 21, 2022
CompletedOctober 21, 2022
September 1, 2022
1.7 years
April 17, 2009
September 23, 2022
September 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12
ACR20 response: greater than or equal to (\>=) 20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
Week 12
Secondary Outcomes (15)
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10
Week 2, 4, 6, 8, 10
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12
Week 2, 4, 6, 8, 10, 12
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12
Week 2, 4, 6, 8, 10, 12
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP)
Baseline, Week 2, 4, 6, 8, 10, 12
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR)
Baseline, Week 2, 4, 6, 8, 10, 12
- +10 more secondary outcomes
Study Arms (5)
Arm 1
PLACEBO COMPARATORPart 1: Placebo
Arm 2
EXPERIMENTALPart 1: 100 mg ILV-094 SC Q4W
Arm 3
EXPERIMENTALPart 1: 100 mg ILV-094 SC Q2W
Arm 4
PLACEBO COMPARATORArm 5
EXPERIMENTALPart 2: 200 mg ILV-094 SC Q2W
Interventions
Eligibility Criteria
You may qualify if:
- Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
- Active RA at the time of screening and baseline consisting of \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein \>= 10 mg/L or Erythrocyte Sedimentation Rate \>= 28 mm/h
- Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.
You may not qualify if:
- Subjects with other rheumatic diseases
- Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
- Any prior use of B cell-depleting therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (52)
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85304, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Arthritis Center
Palm Harbor, Florida, 34684, United States
Clinical Research Advantage, Inc.
Sarasota, Florida, 34233, United States
The Arthritis Specialty Centre
Sarasota, Florida, 34233, United States
Diagnostic Rheumatology and Research PC
Indianapolis, Indiana, 46227, United States
Clayton Medical Research
St Louis, Missouri, 63117, United States
Deaconess Hospital
Cincinnati, Ohio, 45219, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading
West Reading, Pennsylvania, 19611, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, 19610, United States
Arthritis Care and Diagnostic Center
Dallas, Texas, 75231, United States
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, 78232, United States
AZ Jan Palfijn
Antwerp, 2170, Belgium
Cliniques Universitaires St Luc Avenue Hippocrate 10 UCL
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Reuma Instituut
Hasselt, 3500, Belgium
Chu Liege Sart Tilman B 35
Liège, 4000, Belgium
Centro de Reumatologia y Ortopedia
Barranquilla, Atlántico, Colombia
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota, Cundinamarca, Colombia
Medicity S.A.S
Bucaramanga, Santander Department, Colombia
Servimed EU
Bucaramanga, Santander Department, Colombia
University Hospital Centre Rijeka
Rijeka, 51000, Croatia
University Hospital Center Zagreb
Zagreb, 10000, Croatia
Klinikum Innenstadt der Ludwig-Maximillians-Universität
München, 80336, Germany
Budai Irgalmasrendi Hospital
Budapest, 1023, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
Nyíregyháza, 4400, Hungary
Markusovszky Hospital
Szombathely, 9700, Hungary
National Hospital Organization Shimoshizu National Hospital
Yotsukaidou, Chiba, 284-0003, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, 228-8522, Japan
Medical Corporation Wakoukai Kurashiki Kousai Hospital
Kurashiki, Okayama-ken, 712-8044, Japan
Institute of Rheumatology, Tokyo Women's Medical University Hospital
Shinjyuku-ku, Tokyo, 162-0054, Japan
Inoue Hospital
Gunma, 370-0053, Japan
Matsubara Clinic
Hyōgo, 650-0001, Japan
Matsubara Mayflower Hospital
Hyōgo, 673-1462, Japan
Centro de Estudio de Investigacion Basica y Clinica S.C
Jalisco, Guadalajara, 44690, Mexico
AMC
Amsterdam, North Holland, 1105AZ, Netherlands
Centrul Medical Terra Med
Cluj-Napoca, Cluj, 400275, Romania
SC Duo Medical SRL
Bucharest, 010584, Romania
Spitalul Clinic Sf. Maria
Bucharest, 011172, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Centrul de Boli Reumatismale Dr. I. Stoia
Bucharest, 020983, Romania
Spitalul Clinic Judetean de Urgenta Tg Mures
Târgu Mureş, 540136, Romania
Institute of Rheumatology of Russian academy of Medical Scie
Moscow, 115522, Russia
City Clinical Hospital # 1 n.a. Pirogov
Moscow, 119049, Russia
State Educational Institution of Additional Professional Education
Saint Petersburg, 191015, Russia
State Health care institution of Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
State education institution of higher vocational education Smolensk State Medical Academy Roszdrav
Smolensk, 214019, Russia
State Healthcare Institution Yaroslavl Regional Clinical Hospital
Yaroslavl, 150062, Russia
Municipal Institution City Clinical Hospital #40
Yekaterinburg, 620102, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2009
First Posted
April 20, 2009
Study Start
June 18, 2009
Primary Completion
February 18, 2011
Study Completion
February 18, 2011
Last Updated
October 21, 2022
Results First Posted
October 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.